跳至主要内容
临床试验/NCT04797546
NCT04797546撤回1 期

Impact of Adductor Canal Block, Compared to Patient Controlled Analgesia, in the Surgical Stress Response of Patients Programmed for Traumatic Anterior Cruciate Ligament Repair

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Change of Blood Cortisol from baseline to 24 hours

研究概览

简要总结

To evaluate the surgical stress response in anterior cruciate ligament repair with an adductor canal block versus patient controlled endovenous analgesia.

详细描述

Preoperative, 2 hours and 24 hours stress biomarkers will be evaluated in two groups of patients, continous adductor canal block and morphine patient controlled endovenous analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •18-65 years,
  • •traumatic Anterior Cruciate Ligament tear, scheduled for elective arthroscopic repair with Semitendinous-Gracillis technique at first time in the morning, with full articular range,
  • •no other traumatologic lesions.

排除标准

  • •denied consent to participate,
  • •chronic steroids user,
  • •diabetes type 1 or 2,
  • •insulin resistance,
  • •concurrent infectious disease,
  • •cognitive failure, coagulopathy,
  • •allergy to study drugs,
  • •surgery scheduled in the afternoon

研究组 & 干预措施

Adductor Canal Block

Experimental

With mild sedation, a continous bupivacaine 0.1% infusion catheter is placed in the adductor canal. Afterwards, patients are placed under General Anesthesia, and surgery starts. Preoperative, 2 hours and 24 hours stress biomarkers and analgesic quality will be measured.

干预措施: Adductor Canal Block (Procedure)

Patient Controlled Morphine Analgesia

Active Comparator

Patients are placed under General Anesthesia, and after surgery, a Morphine patient controlled analgesia delivery system is installed. Preoperative, 2 hours and 24 hours stress biomarkers and analgesic quality will be measured.

干预措施: Morphine Patient Controlled Analgesia (Device)

结局指标

主要结局

Change of Blood Cortisol from baseline to 24 hours

时间窗: 24 hours

Blood Cortisol will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

次要结局

  • Change of Glycemia from baseline to 24 hours(24 hours)
  • Change of C Reactive Protein from baseline to 24 hours(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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